Back to resultsTissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Primary Purpose
Microtia
Status
Completed
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Platelet-rich plasma (PRP)
Chondrocyte culture with FBS medium
Sponsored by
About this trial
This is an interventional treatment trial for Microtia focused on measuring tissue engineering
Eligibility Criteria
Inclusion Criteria:
- microtia patient
Exclusion Criteria:
- non microtia patient
Sites / Locations
- Taipei Medical University, Wan Fang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Arm A
Arm B
Arm Description
Chondrocyte culture with FBS medium
Chondrocyte culture with PRP
Outcomes
Primary Outcome Measures
The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.
Secondary Outcome Measures
Full Information
NCT ID
NCT00958802
First Posted
August 12, 2009
Last Updated
November 18, 2010
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00958802
Brief Title
Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Official Title
Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Platelet-rich plasma (PRP) has mixed growth factors such as TGF-ß1 and TGF-ß2, vascular epithelial growth factor (VEGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF). These growth factors appear to play an important role in wound healing and are assumed as promoters of tissue regeneration. Moreover, PRP was used as injectable scaffold seeded with chondrocytes to regenerate cartilage. In their previous study, the investigators concluded that growth factors in PRP can effectively react as a growth factor cocktail to induce human nucleus pulposus proliferation and differentiation, and also promote tissue-engineered nucleus pulposus formation. The investigators also have a hypothesis that PRP can promote tissue-engineered microtia auricular cartilage formation. TGF- ß1 exists in the highest concentration and is more important among all of the growth factors released from PRP. So TGF- ß1 can be used as the core ingredient and the indicator for applying PRP in these studies. The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microtia
Keywords
tissue engineering
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Placebo Comparator
Arm Description
Chondrocyte culture with FBS medium
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Chondrocyte culture with PRP
Intervention Type
Other
Intervention Name(s)
Platelet-rich plasma (PRP)
Intervention Description
PRP was extracted from total blood and TGF-b1 was used as indicator
Intervention Type
Other
Intervention Name(s)
Chondrocyte culture with FBS medium
Intervention Description
Microtia chondrocyte culture with FBS medium only
Primary Outcome Measure Information:
Title
The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
microtia patient
Exclusion Criteria:
non microtia patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Che Wu, MD
Organizational Affiliation
Chia-Che Wu
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Medical University, Wan Fang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
12. IPD Sharing Statement
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Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
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